Country: Israel
Language: English
Source: Ministry of Health
PROPOFOL
TARO INTERNATIONAL LTD, ISRAEL
N01AX10
EMULSION FOR INJECTION OR INFUSION
PROPOFOL 10 MG/ML
I.V
Required
SYNTHON HISPANIA S.L., SPAIN
PROPOFOL
PROPOFOL
Diprofol 1% is a short-acting intravenous general anaesthetic for:• Induction and maintenance of general anaesthesia in adults and children > 1 month.• Sedation of ventilated patients > 16 years of age in the intensive care unit.• Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month..
2020-01-31
ורת לנוישנרטניא מ"עב רוטיקה 14 , .ד.ת 10347 הפיח ץרפמ , 2624761 :לט 04-8475700 :סקפ 04-8727165 רבמבונ 2018 ה/דבכנ ה/אפור ת/דבכנ ת/חקור יכ םכעידוהל תשקבמ ורת תרבח אפורל םינולעה לש רישכתה םי DIPROFOL 1% AMP AND VIALS AND DIPROFOL 2% VIALS כדוע ונ . םהב םיפיעסה קר םיניוצמ וז העדוהב םייתוהמ םייוניש ושענ אפורל םינולעב עבצב ונמוס תופסות . םודא , לוחכ עבצב ונמוס תוקיחמה ב הקיחמ וק . ולעה ן כדועמה ן מוסרפ ךרוצל תואירבה דרשמל חלשנ ו :תואירבה דרשמ רתאבש תופורתה רגאמב www.health.gov.il לבקל ןתינו ו :םושירה לעבל היינפ ידי לע ספדומ ורת לנוישנרטניא רוטיקה בוחר ,מ"עב 14 ד.ת , 10347 הפיח ץרפמ 2624761 . ,הכרבב ןמדלוג הנירמ הנוממ תחקור DIPROFOL 1%, AMPOULES AND VIALS ליעפ ביכרמ : Propofol 10mg/ml היוותהה :רישכתל תרשואמה Diprofol 1% is a short-acting intravenous general anaesthetic for: induction and maintenance of general anaesthesia in adults and children > 1 month. sedation of ventilated patients >16 years of age in the intensive care unit. sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month. םינוכדע ל ןולעב אפור : 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The benefits and risks of the proposed procedure should be considered prior to proceeding with repeated or prolonged use (>3 hours) of propofol in young children (< 3 years) and in pregnant women as there have been reports of neurotoxicity in preclinical studies, see Section 5.3. _ _ 5.3 _ _ PRECLINICAL SAFETY DATA _ _ Published studies in animals demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis res Read the complete document
DIPROFOL ® 1% Propofol 1% For IV Administration 1. NAME OF THE MEDICINAL PRODUCT Diprofol 1% (propofol 10 mg/ml). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diprofol 10 mg/ml, emulsion for injection or infusion, contains 10 mg/ml propofol. The solution contains as excipients soybean oil and egg lecithin, which are also used in intravenous feeding. It contains no preservatives. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection or infusion. Diprofol is a white, aqueous isotonic oil-in-water emulsion for intravenous administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diprofol 1% is a short-acting intravenous general anaesthetic for: • induction and maintenance of general anaesthesia in adults and children > 1 month. • sedation of ventilated patients > 16 years of age in the intensive care unit. • sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Propofol must be used only in well equipped hospitals or medical centers by doctors trained in anaesthesia or the treatment of intensive care patients. Continual monitoring of the circulation and the respiration (for example, ECG pulse oxymeter) is necessary. Provisions for prevention of airway obstruction, artificial respiration and other resuscitation provisions must be immediately available at all times. As regards sedation during surgical or diagnostic operations propofol must not be administered by the same person who performs the surgical or diagnostic operation. Additional analgesics are generally necessary in combination with propofol. 4.2.1 INDUCTION OF GENERAL ANAESTHESIA ADULTS In unpremedicated and premedicated patients, it is recommended that Diprofol 1% should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of Read the complete document